The Center for
Genetics and Society's new report,
The California Stem Cell Research Program at One Year: A Progress
Report, was extensively covered in major California newspapers
after its release last week. The 32-page study documents the numerous
ways in which the California Institute for Regenerative Medicine
(CIRM) has failed the public interest during its first year of operation.
The report recommends major changes in the CIRM's policies, and
calls for the chair of its governing board, Robert Klein, to step
down. The overall grade it assigns to the institute for its first
year is C-.
combination of exaggerated promises, political polarization, and
insufficient oversight makes this an especially critical time to
put in place the regulations that are needed if research on stem
cells and other emerging biotechnologies is to be pursued in a responsible
and effective manner.
A sharply worded
of the CIRM by the Los Angeles Times editorial board,
which strongly endorsed Proposition 71, echoed the concerns raised
by the Progress Report.
of the CGS Progress Report
Progress Report, authored by Jesse Reynolds and Marcy Darnovsky
of CGS, calls for action in three broad areas. First, the CIRM should
fulfill its campaign promises, such as ensuring financial returns
to the state. Second, the CIRM should move quickly to establish
accountable and responsible governance. Towards this end, Robert
Klein should step down as chair of the CIRM's governing board. Finally,
the CIRM should adopt enforceable ethical safeguards and research
standards, such as those that will protect women who may provide
eggs for the research.
stem cell program and the recent cloning scandals hold important
lessons for legislators in other states and in Congress. A number
other states are considering their own stem cell research programs.
will benefit from publicly funded stem cell research?
Since the launch
of the California stem cell program, CGS and other public interest
groups have been pressuring the agency to ensure that the state
of California will receive a share of profits generated by any successful
CIRM-funded research, and that any treatments resulting from the
research are broadly accessible.
Report faults the agency's leadership for backtracking on campaign
promises on those points, and recommends that the CIRM "develop
and adopt intellectual property policies that ensure financial returns"
and "ensure the affordability and accessibility of any successfully
developed stem cell-based treatments." Another report, issued
last week by the Foundation
for Taxpayer and Consumer Rights, advocates intellectual property
policies rooted in "affordability,
accessibility, and accountability."
has proposed a plan for managing the ownership of inventions
that addresses these areas.
This week, a
task force of the CIRM's governing board recommended an intellectual
property policy that would require a quarter of each grantee's share
of revenues to be returned to the state. The policy also calls for
a double track for ensuring the affordability of any treatments.
The manufacturers of any product developed with CIRM-funded research
would be required to offer it to state health programs, such as
Medi-Cal, at the lowest available price. And the manufacturers would
be required to develop and implement plans for offering the products
to the state's uninsured population. The state could "march-in"
and revoke a license if a manufacturer failed to follow through
with its plan.
The plan still
must be approved by the full governing board. It is on the agenda
of its February 10 meeting in Palo Alto.
plan likely to be reintroduced by California legislator
Deborah Ortiz (D-Sacramento) may reintroduce her legislation to
reform the state stem cell research program. A supporter of the
initiative that created the state program, she tabled part of her
reform package last year after negotiations with the CIRM. Another
part was vetoed by the Governor. In a recent
speech, she outlined where she feels the CIRM still falls short,
and said that she would devote her last year in office to strengthening
these areas by reintroducing her proposals.
cell effort mired in legal bog, global scandal," San
Francisco Chronicle (January 22)
Cell Fallout," San Francisco Chronicle (January
on hold, but stem cell work on," Oakland Tribune
California can learn from Korean cloning scandal," San
Francisco Chronicle (December 13, 2005)